Effects of Two In-hospital Antepartum Interventions on Functional Ability and Quality of Life in Early Postpartum Women.

Not Applicable

Completed

• Conditions: High-Risk Pregnancy

• Registration Number: NCT02239341
• Lead Sponsor: Western University, Canada

Brief Summary

The current standard of care for pregnant women deemed to be high-risk often involves recommending varying levels of activity-restriction, up to and including hospitalization. High levels of activity-restriction can lead to physical deconditioning of the mother, which can be difficult to recover from after birth. The proposed study will investigate whether a mild muscular conditioning program conducted in bed and given to hospitalized activity-restricted high-risk pregnant women will improve functional ability, cardiovascular deconditioning and overall quality of life in the postpartum period compared to a control group with no in hospital bed-rest exercise program. We hypothesize that women with a in-hospital muscle conditioning program will be better able to perform functional ability tasks and activities of daily living than a control group with no exercise program.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-08
• Study First Submitted QC: 2014-09-10
• Study First Posted: 2014-09-12
• Study Start: 2014-10-30
• Primary Completion: 2017-11-30
• Study Completion: 2017-12-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-04
• Last Update Posted: 2023-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 9

Inclusion Criteria

• Hospitalized high-risk pregnant women in hospital for at least 7 days
• Diagnosed with gestational hypertension
• Diagnosed with preeclampsia (mild to moderate)
• Diagnosed with intrauterine growth restriction
• Single baby
• Expecting twins
• Expecting triplets
• Diagnosed with shortened cervix
• Diagnosed with threatened pre-term labour (not actively contracting)

Exclusion Criteria

• Diagnosed with symptomatic placenta previa (bleeding)
• Diagnosed with severe pre-eclampsia (immediate delivery)
• Diagnosed with conditions indicating a short term hospital stays of less than 7 days
• Diagnosed with infections
• Diagnosed with heart and renal disease
• Diagnosed with diabetes
• Diagnosed with metabolic bone disease
• Diagnosed with hyper-or-hypo-thyroidism
• Diagnosed with Cushing disease and anemia
• Women carrying more than 3 babies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Score on the Functional Mobility Assessment Tool	2 weeks post delivery	The Functional Mobility Assessment Tool was adapted from a senior fitness test, which uses 7 tests to assess muscular strength, aerobic endurance, flexibility and agility (Chair Stand Test, Arm Curl Test, 6-Minute Walk Test, 2-Minute Step Test, Chair Sit-And-Reach Test, Back Scratch Test, and 8-Foot-Up-And-Go Test).

Secondary Outcome Measures

Name	Time	Method
Follow up to Primary outcome Score for Functional Mobility Assessment Tool	2, 6 and 12 months	Changes over time within groups and between groups in the post partum period
Quality of life	Baseline (> 28 weeks gestation); 2 weeks post delivery; 2, 6 and 12 months post delivery	The secondary outcome of the study is to examine quality of life in the postpartum period. Quality of life will be measured by completing four surveys the EQ-5D, and the Postpartum Psychological Profile Questionnaire which includes the Depression Scale (1 page), the State Anxiety Index (1 page) and the Postpartum Physical and Psychological Symptoms Report .

Trial Locations

Locations (1)

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada